iTero Element 5D
K-Number: K193659 · 2020-03-20
ApplicantAlign Technology, Inc.
Decision Date2020-03-20
Product CodeNTK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
iTero Element 5D is a medical device manufactured by Align Technology, Inc.. It received FDA 510(k) clearance on 2020-03-20 under approval number K193659. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iTero Element 5D?
iTero Element 5D is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by Align Technology, Inc.. The 510(k) number is K193659.
When was iTero Element 5D approved by the FDA?
iTero Element 5D received FDA 510(k) clearance on 2020-03-20, under approval number K193659.
What company makes iTero Element 5D?
iTero Element 5D is manufactured by Align Technology, Inc..
What is the FDA product code for iTero Element 5D?
The FDA product code for iTero Element 5D is NTK.
Other Devices by Align Technology, Inc.
Related Devices (Code: NTK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.